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LEVOCARNITINE PAEDIATRIC 30% Oral solution (2018)

Product Name and Form

Levocarnitine Paediatric 30% Oral Solution.

Pharmaceutical form

Oral solution.

Colourless to yellowish, clear solution.

Qualitative and Quantitative Composition

Levocarnitine 30% w/v (300mg/ml).

Excipients with known effect:

Sorbitol solution (70%) (E420)
Sodium propyl hydroxybenzoate (E217)
Sodium methyl hydroxybenzoate (E219)
Sucrose
Hydrochloric acid, concentrated (for pH-adjustment) (E507)

For the full list of excipients, see section 6.1.

List of excipients

Sorbitol solution (70%) (E420)
Sodium propyl hydroxybenzoate (E217)
Sodium methyl hydroxybenzoate (E219)
Sucrose
Hydrochloric acid,concentrated (E507) (for pH-adjustment)

Pack sizes and Marketing

Carton box that contains an amber glass bottle with 20ml of drug product, with a plastic polypropylene and low density polyethylene child proof cap and a graduated dosage pipette, along with the patient information leaflet.

Marketing authorization holder
Authorization dates

Cenoté Pharma Ltd., Griffins Court, 24-32 London Road, Newbury, Berkshire, RG14 1JX, UK

11/01/2018

Marketing authorization number:

PL 46052/0001